|Publication number||US6935384 B2|
|Application number||US 10/370,029|
|Publication date||Aug 30, 2005|
|Filing date||Feb 19, 2003|
|Priority date||Feb 19, 2003|
|Also published as||US20040159364, WO2004073554A2, WO2004073554A3|
|Publication number||10370029, 370029, US 6935384 B2, US 6935384B2, US-B2-6935384, US6935384 B2, US6935384B2|
|Inventors||Sergio Landau, John R. Marshall|
|Original Assignee||Bioject Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (52), Referenced by (9), Classifications (9), Legal Events (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
It is often desirable to deliver inoculations, medications, or other injectable substances to a large number of recipients. For example, it has been shown that vaccinations are an effective method for reducing and/or eliminating the spread of communicable diseases. However, the delivery of injections to large numbers of people presents several problems including expense, difficulty of transportation, cross-contamination between recipients, and the creation of hazardous biowaste. These problems can be compounded in economically deprived areas where resources may be limited.
Current methods for delivering vaccinations to populations of recipients typically use needled syringes. These methods typically require filling of the syringes and disposal of the needle and syringe after each use. Even in the hands of the most careful users, accidental needle sticks, and the accompanying concerns about cross-contamination take place.
Needle-free injection systems allow a faster immunization process than needled syringes and eliminate the possibility of accidental needle sticks. However, because the nozzle of the needle-free injector (rather than a disposable needle) makes contact with the patient during injection, the use of current needle-free injection systems to inject multiple patients raise concerns about contamination unless the equipment is properly sterilized between injections. Therefore, it is important that equipment is properly sterilized between injections. However, this can increase costs and reduce the number of injections that can be administered in a given time period, decreasing the likelihood that everyone who needs or wants a vaccination will receive one.
In one embodiment, the present invention provides a needle free injection system including an injection assembly and a filling device. The injection assembly may include a single-use fluid ejection assembly and a propulsion assembly. The single-use injection assembly may include a body terminating in a nozzle, a fluid reservoir housed within the body, and a plunger disposed within the fluid reservoir. The propulsion assembly may include a housing adapted to receive at least a portion of the removable fluid ejection assembly and a propulsion system adapted to apply sufficient force to the fluid ejection assembly to cause ejection of the fluid injectate through the nozzle. The filling assembly may be adapted to sterilely deliver a predetermined amount of injectate from a common reservoir to a plurality of fluid ejection assemblies.
In one embodiment the invention provides a high throughput needle-free injection system. As shown, system 10 may include a filling device 12 and a needle-free injection assembly 14. Filling device 12 is adapted to sterilely transfer a predetermined amount of injectate from a reservoir 16 to a plurality of fluid ejection assemblies 18 via a fluid path 20. As shown, a carrier 22 may hold or otherwise join two or more of the fluid ejection assemblies 18 together. In some embodiments, all components of the filling device that come into contact with the injectate, including the reservoir, fluid path, and fluid ejection assemblies may be disposable. Some components, such as the reservoir or fluid ejection assemblies may be single-use, such that once their contents are depleted they are thrown away. Other components, such as the fluid path, may be used for a given period of time, such as a day, or for a certain number of uses, such as for 100 cartridge fillings, and then disposed of.
Needle-free injection assembly 14 includes a propulsion assembly 24 and may removably engage a filled fluid ejection assembly 18. Upon activation by a user, injection assembly 14 may eject the contents of the fluid ejection assembly 18 with sufficient velocity to deliver the injectate to a desired target, such as beneath the dermal layers of a recipient.
Typically, a new fluid ejection assembly 18 is inserted into needle-free injection assembly 14 before each injection. As shown, the fluid ejection assembly 18 may be seated within needle-free injection assembly 14. Fluid ejection assembly 18 may include a first portion 18 b that is inserted into needle-free injection assembly 14 and a second portion 18 c that is exposed. Typically, this exposed portion is placed against the patient during an injection. Thus, fluid ejection assembly 18 may be designed such that only the replaceable fluid ejection assembly 18 and no portion of needle-free injection assembly 14 makes contact with the patient during an injection.
An exemplary high throughput needle-free injection system 110 is shown in FIG. 2. As shown, system 110 includes a filling station 112 and a reusable needle-free injector 114. In system 110, filling station 112 is adapted to sterilely transfer a predetermined amount of injectate from a fluid reservoir, which in the embodiment shown takes the form of a syringe 116, to a plurality of disposable cartridges 118. As shown, a cartridge rack 122 joins the plurality of disposable cartridges together.
Syringe 116 includes a syringe reservoir 134 terminating in a nozzle 136 through which fluid in the syringe may be expelled. Syringe 116 further includes a plunger 138 having a first end 138 a that terminates in a thumbpad 140 and a second end 138 b that is received by syringe reservoir 134. Syringe 116 may be a commercially available syringe, such as the BD™ syringe, available from Becton, Dickinson and Company or other syringes such as those sold by Monoject, and Terumo. Typically, syringe 116 is able to store enough injectate to fill a number of cartridges. It should be appreciated that the size and capacity of syringe 116 may depend on availability, the size of filling station 112, the number of cartridges it is desired to fill, the shelf life of the injectate, and other relevant factors. As a non-limiting example, syringe 116 may take the form of a 60 cc syringe. However, it should be appreciated that other sizes and other types of non-syringe fluid reservoirs may be used with the present invention.
As previously stated, filler valve 120 provides a fluid path between syringe 116 and each of the cartridges during the filling process.
It will be appreciated that in the embodiment described above, the entire fluid path consists of syringe 116, filler valve 120, and cartridges 118. Thus, any injectate introduced into the system makes contact only with syringe 116, filler valve 120, and cartridges 118. It should further be appreciated that each of these components may be disposable. In some cases, syringe 116 and each cartridge 118 may be “single use,” i.e., used once and then thrown away. Because a single-use filler valve may not be practical, it may be desirable to use filler valve 120 for a given period of time, for example, several hours, half a day, or a day before being disposed of. Alternatively filler valve 120 may be used to fill a certain number of cartridges, for example, 50, 100, or 500 and then disposed of.
A spring 132 is housed in each tubular rod 128. Spring 132 includes a first end 132 a and a second end 132 b. First end 132 a of spring 132 is attached to first end 128 a of tubular rods 128. Second end 132 b of spring 132 is attached to second end 130 b of sliding rods 130. When sliding rod 130 is in the “up” position, as depicted in
Syringe seat 156 is shaped to complement the external contour of the lower end of syringe 116. When the syringe is properly positioned in syringe seat 156, syringe nozzle 136 contacts aperture 120 b of filling valve 120. In this position, plate 158 rests on thumbpad 140 of plunger 138.
When extended, spring 132 is biased to pull first end 128 a of tubular rod 128 toward second end 130 b of sliding rod 130. Because plate 158 is affixed to tubular rod 128, this bias essentially creates a downward force on plate 158. This downward force is applied by plate 158 on thumbpad 140 of plunger 138. Thus, as the contents of syringe 116 are released into the cartridges (i.e. as the cartridges are filled) the downward force on plunger 138 pushes plunger 138 further into syringe reservoir 134 until it meets resistance from liquid injectate inside the syringe reservoir. Put briefly, the force created by extended spring 132 is transmitted to syringe 116, so that the internal contents of syringe 116 are placed under constant pressure.
Filling station 112 includes a series of cams 164 attached to a rotating shaft 166. Each cam 164 is associated with a spring-loaded pin 168. Center cam 170 controls central pin 172, which is responsible for positioning and retaining cartridge 118 against the opening of filler valve 120. External cams 174 and 176 control external pins 178 and 180, respectively, which are affixed to block 182.
Rotation of shaft 166 after cartridge 118 is positioned against filler valve 120 results in a slight downward movement of pins 178 and 180 and a corresponding slight downward movement of block 182. Downward movement of block 182 compresses spring 120 d on filling valve 120, opening the valve.
Thus, the opening of valve 120 allows fluid in syringe 116 to flow into cartridge 118. As cartridge 118 fills with fluid, a plunger 118 a within cartridge 118 is pushed downwards to the bottom of the cartridge. When cartridge 118 is full, plunger 118 a meets end 184 of central pin 172. Once the cartridge is filled, pin 186 acts as a cog, moving cartridge rack 122 through the filling station until positioning pin 190 properly positions the next empty cartridge in the filling station.
Typically, filling device 112 includes a power generator to control operation of the device. It will be appreciated that the power generator may be a user, motor, pump, or other mechanism.
For example, as described above, movement of pins 172, 178, 180, 186 and 190 is controlled and powered by rotation of shaft 166. Rotation of shaft 166 may be electronic, motor-driven, hand-driven, or the like. If rotation of shaft 166 is hand-driven, filling station 112 may include a hand crank 194 (also shown in FIG. 2). In the depicted embodiment, movement of hand crank 194 rotates belt 196, which engages and thus rotates shaft 166. Thus, in this embodiment, the power generator includes a user operating a hand crank.
Turning briefly to
It should be appreciated that it may be desirable for cartridge 118 to be a single use or disposable cartridge that, once spent, cannot be reused. Consequently, it will be appreciated that some materials are more useful for disposable cartridges. For example, plastics, which are lightweight and inexpensive, tend to be suitable for disposable applications.
As shown in
Those of skill in the art will be familiar with various propulsion assemblies useful for needle-free injectors. Suitable needle-free injectors include those described in U.S. Pat. Nos. 4,941,880, 5,064,413, 5,312,335, 5,383,851, 5,399,163, 5,520,639, 5,993,412, 6,096,002, 6,264,629, 6,383,168, 6,471,669, and co-pending U.S. Ser. No. 10/164,920, each of which is hereby incorporated by reference in its entirety for all purposes.
Generally, the propulsion assembly is adapted to engage cartridge 118 and directly or indirectly advance plunger 118 a towards nozzle end 118 c. The movement of plunger 118 a should expel liquid injectate in cartridge 118 from nozzle 118 c with sufficient pressure to allow the fluid to penetrate the target, such as the dermal layers of a patient's skin, to the desired degree. As stated above, trigger 210 typically controls activation of the propulsion assembly. However, it should be appreciated that other controllers could be used, including user-activated buttons, touch pads, levers or the like.
Chuck 206 is adapted to removably engage a filled cartridge 118 such that a nozzle end 118 c of the cartridge 118 is presented for placement against the patient. Pulling lever 200 towards grip 202 opens chuck 204 so that the shaft 118 u of filled cartridge 118 may be partially inserted into the barrel portion 202. Lever 200 may then be pushed forward to lock the cartridge into place. After an injection, lever 200 may once again be pulled backwards to open chuck 202 and release the spent cartridge.
The present invention provides a system and apparatus for high throughput needle-free injections. It is believed that the disclosure set forth above encompasses multiple distinct inventions with independent utility. While each of these inventions has been disclosed in its preferred form, the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense, as numerous variations are possible. The subject matter of the inventions includes all novel and non-obvious combinations and subcombinations of the various elements, features, functions and/or properties disclosed herein. Similarly, where the claims recite “a” or “a first” element or the equivalent thereof, such claims should be understood to include one or more such elements, neither requiring nor excluding two or more such elements.
It is believed that the following claims particularly point out certain combinations and subcombinations that are directed to one of the disclosed inventions and are novel and non-obvious. Inventions embodied in other combinations and subcombinations of features, functions, elements and/or properties may be claimed through amendment of the present claims or presentation of new claims in this or a related application. Such amended or new claims, whether they are directed to a different invention or directed to the same invention, whether different, broader, narrower or equal in scope to the original claims, are also regarded as included within the subject matter of the inventions of the present disclosure.
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|U.S. Classification||141/2, 141/27, 141/129, 141/9|
|International Classification||B65B3/00, A61M5/178|
|Cooperative Classification||B65B3/003, A61M5/1782|
|Aug 27, 2003||AS||Assignment|
Owner name: BIOJECT INC., OREGON
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LANDAU, SERGIO;MARSHALL, JOHN R.;REEL/FRAME:014454/0795
Effective date: 20030219
|Mar 29, 2006||AS||Assignment|
Owner name: PARTNERS FOR GROWTH, L.P.,CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:BIOJECT, INC.;REEL/FRAME:017379/0255
Effective date: 20060329
|Dec 11, 2006||AS||Assignment|
Owner name: PARTNERS FOR GROWTH, L.P.,CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:BIOJECT, INC.;REEL/FRAME:018606/0671
Effective date: 20061211
|Sep 4, 2007||AS||Assignment|
Owner name: PARTNERS FOR GROWTH, L.P.,CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:BIOJECT, INC.;REEL/FRAME:019773/0642
Effective date: 20070831
|Mar 9, 2009||REMI||Maintenance fee reminder mailed|
|Aug 30, 2009||LAPS||Lapse for failure to pay maintenance fees|
|Oct 20, 2009||FP||Expired due to failure to pay maintenance fee|
Effective date: 20090830